SUPPLY CHAIN ARTICLES
-
Beyond The Gold Standard(s): Modernizing Oligonucleotide Synthesis
A few weeks ago, I had the chance to sit down with OPT Congress speaker Phil Baran, Richard Lerner Chair Professor, Department of Chemistry, Scripps Research. Baran was slated to (and did) present a keynote on the innovations shaping the next generation of oligo synthesis. Here, I share the biggest takeaways I had from our conversation, touching on how he sees the science of oligo chemistry and manufacturing advancing in the near and far future.
-
ARW's ATMP Manufacturing Must-Reads (ST. PATRICK'S DAY EDITION!)
Day-in and day-out, I write, read, listen to, and watch as much content as I can about CGT and RNA therapy manufacturing, in particular, and/or other ATMP industry-related topics that you should at least be aware of in the manufacturing facility. Once a month, I compile the articles and industry updates I think are most worthy of your time into an unconventional roundup article.
-
Picasso, Pick-Up Lines, & Personalized Medicine: mRNA's Path Forward
Overall, my presentation on what the mRNA industry can learn from the artist Picasso singled out a few specific areas from which I felt our industry could garner greater inspiration and operational prowess. But given how “collaborative” many of these sources of inspiration are, I’ve introduced each of my takeaways with a surprisingly relevant (albeit bad) art-themed pick-up line. After all, if there’s one sector that knows it takes more than one to “tango,” it’s the mRNA industry.
-
5 Critical Regulatory Topics To Watch In The Oligo Sector
Though our guidances have helped us achieve upwards of 20 commercially approved oligo products, as I listened to GSK’s director of CMC policy and advocacy, Katie Duncan, present at TIDES, it struck me just how far we have yet to come. Here, I single out a few of the biggest topics of regulatory discussion shaping the oligo therapeutics market.
-
“To Thine Own [mRNA Product] Be True:” Shakespeare's Guide To RNA GMP Principles
In the following article, I offer some of the biggest tips and tricks experts offered during a panel discussion on the challenges of navigating GMP principles in the RNA space today — with a little bit of help from Shakespeare himself.
-
Can America's Retreat On mRNA Be Europe's Opportunity?
With HHS winding down mRNA vaccine development under BARDA, could Europe seize the opportunity to lead in mRNA innovation? Exploring the policy shift's implications.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
-
Explore the challenges impacting clinical supply chains and solutions to overcome these complexities, and understand why it is crucial to pick the right supply chain provider for vaccine storage and distribution.
-
Protect patient safety and ensure regulatory compliance by implementing sensitive, reliable bacterial endotoxin testing as a critical component of pharmaceutical quality assurance.
-
As gene therapy organizations are asked to balance the need for rapid clinical progression and stringent quality expectations, explore how to optimize plasmid production and reach patients with efficiency.
-
This review suggests technical remedial options for the production of pDNA and focuses on mRNA synthesis, purification, and encapsulation.
-
Learn how a robust understanding of the RNP’s critical process parameters and CQAs is crucial for ensuring product consistency, enhancing patient safety, and maintaining regulatory compliance.
-
Drive the efficiency and resiliency of supply chains by integrating automation, AI, and effective communication, ensuring the successful distribution of lifesaving medicinal products.
-
Single-use technology is vital for ensuring the quality and expedited market entry of genomic medicines. Learn how LNP technology is paving the way for a new era of personalized, precise medicine.